TITLE: Fast Track? IND enabling studies for Oral Cancer PROJECT SUMMARY According to the Oral Cancer (OC) Foundation, oral and pharyngeal cancer will cause 8,000 deaths this year in the US, killing roughly one person per hour. Currently, cisplatin (CIS) is at the forefront of platinum-based chemotherapeutics for treating OC. However, its efficacy is often hindered by its significant systemic toxicity as a result of traditional bolus systemic intravenous (IV) doses. In this proposal entitled ?Fast-track: IND enabling studies for Oral Cancer?, the critical path is performing the studies required by the FDA to successfully achieve the the IND status for safety trials. Privo's specific aims for phase I focus on conducting in-vivo studies to further fine tune the dosing of Privo's lead optimized formulation for its ChemoThin Wafer (CTW). For the Phase II of this project, the focus is on conducting IND enabling studies to prepare Privo for human safety trial. Privo's CTW contains anticancer chemotherapy agent; cisplatin which is the gold standard chemotherapy drug for oral cancer. It is designed and optimized for local and topical treatment of OC, thus replacing injection, increasing the drug's efficacy and significantly reducing its systemic toxicity. The CTW platform contains FDA approved chemotherapy drugs and generally recognized as safe (GRAS) materials. It utilizes nano-encapsulation techniques to incorporate drugs into NPs with a controlled-release design that releases chemo drugs at fully tunable and pre-determined rates. The 5-year survival of patients with OC has not significantly improved over the past several decades. Moreover, the survival rate for early detection is significantly higher than later stages (80-90% vs. 25- 35%). Therefore, for patients with pre-malignant to non-metastasized malignant OC, this reformulated nano-encapsulated CTW delivery platform has the opportunity to considerably reduce the morbidity and mortality rate of this devastating cancer. The ultimate objective of Privo Technologies is to develop and commercialize effective, safe and convenient chemotherapy treatments accessible to many patients.